FDA No more free samples? Well...

[AgentAnia]

Just found this in a Boston Globe article: FDA e-cigarette plan brings complaints from both sides - Metro - The Boston Globe

The FDA has not said when the regulations would take effect. Thursday’s release started a 75-day comment period, after which the FDA will review feedback and issue the final rules as quickly as possible, said spokeswoman Stephanie Yao. She said the proposed ban on free samples covers in-store sampling, freebies from manufacturers to retailers, and giveaways to customers.

This is the first time I, at least, have seen this confirmed by someone from FDA.

It seems to me that all that's required to continue in-store sampling is to charge for it, and I don't see any "quidelines" on how much (or how little) could be charged, so pennies, I would think. Or a by-subscription "tasters club."

Am I being naive?

(On a side note, I fail to see how, in stores that prohibit entry to anyone under 18, restricting free samples will "save the children," but obviously (and thankfully) I don't think like the FDA does.)

 

[MorpheusPA]

It's too easy to get around. The FDA can't set prices for retailers, so if stores wish to have samples with nicotine in them, they simply have to charge a penny for access to the flavors. The fact that there's a "Take a Penny" bin right next to the cash register and it's always kept full is really not the retailer's problem.

Alternately, use zero-nic in the sample section. The FDA has no authority over it.

 

[Kryyptyk]

...they simply have to charge a penny for access to the flavors. The fact that there's a "Take a Penny" bin right next to the cash register and it's always kept full is really not the retailer's problem.

This. It's really no different from the candy sampling you do in a grocery store.

 

[AgentAnia]

It's too easy to get around. The FDA can't set prices for retailers, so if stores wish to have samples with nicotine in them, they simply have to charge a penny for access to the flavors. The fact that there's a "Take a Penny" bin right next to the cash register and it's always kept full is really not the retailer's problem.

Alternately, use zero-nic in the sample section. The FDA has no authority over it.

Yeah, after I opened thread, I remembered that one of my local B&Ms uses 0-nic in samplers.

However, I still plan to include my opposition to this in my comment to FDA. (All of the sampling restrictions, not just this one.)

 

[MorpheusPA]

Yeah, after I opened thread, I remembered that one of my local B&Ms uses 0-nic in samplers.

However, I still plan to include my opposition to this in my comment to FDA. (All of the sampling restrictions, not just this one.)

Sure, why not? Charging anything requires hassle and a human's time. Validation that the person is over 18 and entered the shop of their own free will should be sufficient.

 

[Lurch]

The B&M's that I have visited all use non-nic samples now....

 

[aikanae1]

Nicotine does alter the taste of the eliquid, sometimes significantly. But I think this is easy to get around in the stores. The problem is with eliquid manufacturers since they often send out a free sample with an order. I've discovered many new flavors that I wouldn't have tried this way. Again, if a vendor really wanted to get around that they could.

I think a response to the FDA should be targeted to the specific problems implimenting regulations, not a laundry list of complaints. Yes it's bad. We all know that. The problems putting these regulations in action are equally HUGE. It's pretty obvious tobacco companies wrote this up and I doubt if the FDA did more than glance and agree with it. They did not examine it. They have no idea what they are attempting to regulate. There is the potential for a backlash from vapers who will never, ever pay for a tobacco company related product again even if it means becoming a criminal (me). There are a number of forums involved in this discussion outside of ECF.

However, it's human nature not to be able to focus on more than 3 to 5 things at a time. Choose your battles wisely. I think the framework the FDA is offerring for comments is fairly specific. A general list of complaints will be dismissed. They are looking for evidence that SUPPORTS THEIR CONCLUSIONS. Ugh, I know. But that's the game and it doesn't mean you have to agree.

The fact is, the FDA implimented essentially a ban on flavors without issuing a ban on flavors with their application process. That's how the game is played. One estimate was up to $500,000 for the approval of one flavor of eliquid. These were basic filing and lawyer costs. It was unknown if seperate applications would be required for different nic levels or VG/PG ratios. This is why I don't think the FDA has thought about this and it's a tobacco industry document. What are they going to do with a company specializing in flavors; 100+ flavors x 5 for different nic levels, x5 again for varying ratios x 1,000+ different manufacturers when they can't even clear up a mesily 3,000 applications in 5 years?

Right now I am thinking I am going to focus my comments on the fact that the FDA is ill-equipped for oversight of the vaping industry without fundamental change. Attempting to impliment regulations as they currently are proposed could very well give rise to an underground market that would be an even worse nightmare to control.

There are MANY problems with this that will make working at the FDA feel like working in hell and impractical. Point it out to them.

My opinions are subject to change as I learn and read more. We have yet to hear from CASSA and others. Unlike TVECA, "we" did not get an advanced copy of these, so it's still early in the game.

 

[pamdis]

Speaking of costs, where's the Economic Impact Analysis? Reference 194 in the proposed rule document states that it can be found here:

http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/

But I don't see it.

 

[Myrany]

Speaking of costs, where's the Economic Impact Analysis? Reference 194 in the proposed rule document states that it can be found here:

Economic Impact Analyses of FDA Regulations

But I don't see it.

That might be a place the vendors can really dig into. The economic impact of lost taxes, jobs, businesses if this thing is as draconian as we all fear. If they are enough larger than the FDAs then there is real possibility of a big rewrite there.

Also there is a possibility of getting several other groups on board with us like pipe smokers and those businesses. The same section that could regulate our PVs and toppers can just as easily be interpreted to include tobacco pipes which would effective close both that loophole in the law and the one head shops use. More voices could be a good thing.

 

[Maestro]

I'm reminded of the old days when you couldn't sell margarine the same color as butter so the margarine came with a color capsule for the consumer to add to the margarine. I think the FDA is going to have a VERY difficult time with flavoring.

 

[Craybee]

I'm reminded of the old days when you couldn't sell margarine the same color as butter so the margarine came with a color capsule for the consumer to add to the margarine. I think the FDA is going to have a VERY difficult time with flavoring.

wow. that's just bizarre. how long ago was that?

 

[Maestro]

Probably 50 years or more. It was to protect the dairy industry, at least here in Canada. I'm not sure if the states did the same thing or not. I imagine it wouldn't be difficult to sell unflavored nic along with flavoring (outside of FDA regs) you add yourself.

 

[roach52]

They did do the same for years (before my time but my grandmother told me this a few times) Also similar with the fight on processed cheese like Kraft singles being petitioned to be required to call themselves embalmed cheese product... the big industry didn't want competition. At least in these cases the new product got or eventually got its right to market appropriately without the influence of a competitor.

And whatever sell zero nic and then sell a nic additive so effectively everything becomes non regulated and if you add some nic or flavor so be it. Unfortunately this kind of pushes good small vendors into a grey market many will not want to deal in and in any case we may end up with vendors who are not great or reputable to start with who are the ones willing to cross that line.

I don't know that I really feel it is grey market but many business owners are not going to want to incur the wrath of the FDA its just not worth the trouble for some small businesses. They will find another simpler business to pursue.

Hope this all works out but not much does once government regulations get involved.

My brother had to deal with the FDA for his lab, I remember him getting fined something like $500 because he had accidentally allowed a 2ml pipette to get mixed in the slot for 1ml pipettes. Granted he was dealing with stuff far more toxic than nicotine in an FDA regulated lab.

 

[Youssefa]

People should be VERY VERY VERY careful. By tell the FDA what they can't possibly enforce, will just give them a heads up, and cause them to reword it, NOT IN OUR FAVOR. For example, So you are going to charge a penny for sampling, then we will just make it so you can't have unsealed liquids in your store. or add that you cannot smoke or vape indoors, except on private property.

We need to object and then "smile on the inside" knowing that we will slip through their gaping holes. LOL!

 

[aikanae1]

That might be a place the vendors can really dig into. The economic impact of lost taxes, jobs, businesses if this thing is as draconian as we all fear. If they are enough larger than the FDAs then there is real possibility of a big rewrite there.

Also there is a possibility of getting several other groups on board with us like pipe smokers and those businesses. The same section that could regulate our PVs and toppers can just as easily be interpreted to include tobacco pipes which would effective close both that loophole in the law and the one head shops use. More voices could be a good thing.

I think the definition specifically does say pipes in it. I know people handcraft pipes for a hobby, just like some wood workers do with box mods. I have no idea how they are going to deal with this. Same with drip tips.

I think it's a very good question. The idea that someone's "hobby" can now be made illegal.

 

[Youssefa]

The fact is, the FDA implimented essentially a ban on flavors without issuing a ban on flavors with their application process. That's how the game is played. One estimate was up to $500,000 for the approval of one flavor of eliquid. These were basic filing and lawyer costs. It was unknown if seperate applications would be required for different nic levels or VG/PG ratios. This is why I don't think the FDA has thought about this and it's a tobacco industry document. What are they going to do with a company specializing in flavors; 100+ flavors x 5 for different nic levels, x5 again for varying ratios x 1,000+ different manufacturers when they can't even clear up a mesily 3,000 applications in 5 years?

Right now I am thinking I am going to focus my comments on the fact that the FDA is ill-equipped for oversight of the vaping industry without fundamental change. Attempting to impliment regulations as they currently are proposed could very well give rise to an underground market that would be an even worse nightmare to control.

There are MANY problems with this that will make working at the FDA feel like working in hell and impractical. Point it out to them.

My opinions are subject to change as I learn and read more. We have yet to hear from CASSA and others. Unlike TVECA, "we" did not get an advanced copy of these, so it's still early in the game.

There is the mastodon in the room, So long as the application has been submitted you can sell it until your application is rejected.... So the idea of Scientific analysis and review(regulation) of eliquid to "protect" the consumer is an effen joke on both sides. Just their way of getting paid, appearing to take action and accomplishing NOTHING!

 

[Myrany]

There is the mastodon in the room, So long as the application has been submitted you can sell it until your application is rejected.... So the idea of Scientific analysis and review(regulation) of eliquid to "protect" the consumer is an effen joke on both sides. Just their way of getting paid, appearing to take action and accomplishing NOTHING!

Or rejecting every application with no consideration at all. Killing the devices/liquids there and still raking in the cash while yelling "for the childrens"

Yeah I am that cynical anymore.

DO not forget this is PROPOSED deeming. That 2 year window could vanish in the rewrite before it becomes law.

 

[aikanae1]

Well I think that's why I'm going to wait until there's more anylasis comes out. Just today my opinions have flip flopped several times. Right now they are pretty low. I hope, as a group, we can identify several areas of weakness that the FDA is most vunerable on.

I'm also getting really tired of really dumb comments in the press.

And local bans are marching forward. I think we need a private forum to discuss a black market.

 

[edyle]

Sounds like price control to me.

Wouldn't that be recognised as unconstitutional?

 

[Nermal]

How so, edyle? Nixon did wage and price controls. Didn't work, but he did it. Anyhow, as mentioned, "no free samples" doesn't begin to specify any minimum price.